Findings
Key considerations include accuracy, precision, sampling frequency, resolution, and data processing. Metadata and communication protocols must ensure reliable and secure data collection.
Sponsors must assess data access, security, and compliance with regulations like 21 CFR Part 11. Clarity on manufacturer and sponsor responsibilities is essential for maintaining data integrity.
Safety risks should be minimized, especially for vulnerable populations. Specifications should ensure that devices pose minimal risks when used solely for data capture.
Human Factors: Acceptability, tolerability, and usability directly impact participant recruitment and adherence. Feasibility studies can help evaluate these factors in target populations.
Operational Considerations: Firmware updates, failure rates, battery life, and customer support must be planned for to avoid disruptions in data collection and participant experience.
Non-Performance Specifications: Cost and customer service must be accounted for, ensuring smooth implementation and user support.

Recommendations
Tailor DHT selection to trial needs, focusing on measurement accuracy, precision, and reliability.
Engage sponsors, technology manufacturers, and patient groups to align specifications with practical and clinical requirements.
Ensure compliance with regulatory standards and implement robust processes for secure data transfer and storage.
Test DHTs for usability, tolerability, and operational reliability in representative populations before full-scale implementation.
Develop clear protocols for managing firmware updates, device malfunctions, and participant support to ensure trial continuity.

Regulatory Considerations
Ensure all data management processes comply with regulatory requirements like 21 CFR Part 11 and align with FDA guidance.
Validate DHTs within the target population to confirm their reliability and relevance for the specific trial context.
Clearly communicate how data will be used and shared to maintain ethical standards and informed consent compliance.
Minimize participant risks by selecting devices with proven safety profiles and addressing potential vulnerabilities during feasibility testing.